BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N'VISION

    MDR report key: 1022764 · Received March 28, 2008

    Report

    Report Number
    2182207-2008-01674
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PUMP REPLACEMENT THE CATHETER WAS NOT ASPIRATED AND THE PUMP WAS NOT PRIMED PRIOR TO ATTACHING. THE PUMP WAS FILLED WITH THE SAME UNSPECIFIED DRUG AS WAS IN THE CATHETER (CONCENTRATION 15 MG/ML AT A DOSE OF 3.5 MG/DAY). IT WAS DETERMINED THAT THE PATIENT WOULD RECEIVE DRUG FOR 23 HOURS, THEN NO DRUG WOULD BE RECEIVED FOR 20-30 HOURS, THEN DRUG WOULD BE RECEIVED AGAIN. NO PATIENT SYMPTOMS, TREATMENT OR OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N'VISION LKK MEDTRONIC NEUROMODULATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED,| EXPLANTED:| IMPLANTED:| IMPLANTABLE INFUSION PUMP MODEL 863740| CATHETER MODEL 8578 LOT# N137887| EXPLANTED,| CATHETER MODEL 8703W LOT# L47172| LOT# NGV414310H| EXPLANTED:| IMPLANTED: